An observational study in Heart Failure With Reduced Ejection Fraction, Ventricular Arrhythmia and Ischemic Cardiomyopathy, sponsored by University of Rzeszow. Active, not recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by University of Rzeszow · Observational
This prospective observational study evaluates whether circulating small non-coding RNAs, particularly microRNAs, are associated with ventricular arrhythmias in patients with post-myocardial infarction heart failure who have an implanted cardioverter-defibrillator and are followed by remote monitoring. Blood samples were collected from 57 participants. Small RNA profiles are analyzed in relation to ventricular tachycardia or ventricular fibrillation episodes recorded by the implanted device. Participants are not assigned to any treatment or intervention as part of this study. The initial analysis includes six months of follow-up, with longer-term observational follow-up planned.
This is a single-cohort prospective observational biomarker study in patients with post-myocardial infarction heart failure and an implanted cardioverter-defibrillator or cardiac resynchronization therapy defibrillator who are followed through remote device monitoring.
Peripheral blood was collected from 57 participants for analysis of circulating small RNAs. Following laboratory quality control, including assessment of hemolysis and sequencing quality, 48 samples were included in the primary molecular analysis. Small RNA sequencing is used to characterize circulating RNA profiles, with the main analyses focusing on microRNAs.
RNA profiles are evaluated in relation to clinically relevant ventricular arrhythmias documented by the implanted device, including sustained ventricular tachycardia or ventricular fibrillation requiring antitachycardia pacing or shock. The primary prospective observation period is six months after blood collection. Continued long-term follow-up through remote monitoring is planned through March 2029. Existing clinical information and device-recorded arrhythmia history may also be used for exploratory analyses.
No study-specific treatment is assigned and routine clinical management is not altered by participation. The objective is to identify circulating RNA markers associated with an arrhythmogenic phenotype and to generate candidates for subsequent validation.
451 studies on the registry are indexed under Tachycardia, Ventricular; 120 are open to participants now.
This study's enrollment of 57 is below the median of 167 across 147 observational studies indexed under Tachycardia, Ventricular.
Browse Tachycardia, Ventricular studies →University of Rzeszow is the lead sponsor of 37 studies on the registry; 12 are open to participants now.
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Adult patients receiving cardiology outpatient care for post-myocardial infarction heart failure who have an implanted cardioverter-defibrillator or cardiac resynchronization therapy defibrillator and are followed through a remote monitoring program.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with post-myocardial infarction heart failure and an implanted cardioverter-defibrillator or cardiac resynchronization therapy defibrillator undergoing routine remote monitoring. Circulating small RNA profiles are evaluated in relation to device-recorded ventricular arrhythmias. No treatment is assigned by the study.
Diagnostic Test: Circulating Small RNA Profiling
Peripheral blood collection followed by laboratory isolation and sequencing of circulating small RNAs, with primary focus on microRNAs. The molecular results are analyzed as research biomarkers and are not used to assign treatment or alter routine clinical management.
Differential Expression of Circulating Small Non-Coding RNAs by Ventricular Arrhythmia Phenotype
Normalized expression levels and log2 fold changes of circulating small non-coding RNAs, primarily microRNAs, are compared between participants with and without device-documented life-threatening ventricular arrhythmias or appropriate ICD therapy. Statistical testing includes correction for multiple comparisons.
Time frame: At blood collection; arrhythmia phenotype determined from device records available through blood collection
Occurrence of Sustained Ventricular Arrhythmia Requiring ICD Therapy
Number of participants with at least one device-confirmed episode of sustained ventricular tachycardia or ventricular fibrillation treated with antitachycardia pacing or an ICD shock. Events are identified through routine remote device monitoring.
Time frame: From blood collection through 6 months
Long-Term Occurrence of Sustained Ventricular Arrhythmia Requiring ICD Therapy
Number of participants with at least one device-confirmed episode of sustained ventricular tachycardia or ventricular fibrillation treated with antitachycardia pacing or an ICD shock during extended routine remote monitoring.
Time frame: From blood collection through 3 years
Plan to share: Undecided
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This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of Rzeszow